Cleared Special

SOFIA INFLUENZA A+B FIA

K131606 · Quidel Corp. · Microbiology
Jul 2013
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K131606 is an FDA 510(k) clearance for the SOFIA INFLUENZA A+B FIA, a Antigens, Cf (including Cf Control), Influenza Virus A, B, C (Class I — General Controls, product code GNX), submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on July 5, 2013, 32 days after receiving the submission on June 3, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3330.

Submission Details

510(k) Number K131606 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2013
Decision Date July 05, 2013
Days to Decision 32 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GNX — Antigens, Cf (including Cf Control), Influenza Virus A, B, C
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3330

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